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Completed

NCT Number: NCT04207359

Effects of Creatine Supplementation in Breast Cancer Survivors

The purpose of this study is to test the hypothesis that creatine will accelerate adaptations associated with exercise in breast cancer survivors recently completing chemotherapy.

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Key information

Conditions

Breast Cancer Atrophy Behavior Breast Diseases Breast Neoplasms Chemotherapy Effect Exercise Motor Activity Muscle Loss Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UT Health San Antonio

San Antonio, Texas, 78229, United States

About this study

The primary objective of this study is to determine the effects of creatine supplementation in modulating strength and physical function in breast cancer survivors that have recently completed chemotherapy. The primary hypothesis for this objective is that creatine will lead to significantly greater gains in strength and physical function in breast cancer survivors compared to exercise alone. The secondary objective is to determine if supplemental creatine can increase intramuscular storage of creatine and alter energy storage. The hypothesis for this objective is that creatine supplementation will significantly increase intramuscular concentrations of creatine (Cr), phosphocreatine (PCr) and adenosine triphosphate (ATP) in the vastus lateralis (VL) compared to controls. The secondary hypothesis for this objective is that the creatine group will have significantly greater muscle cross-sectional area and significantly lower intramuscular fat compared to controls. The final objective for this study is to test the hypothesis that creatine supplementation will improve body composition in breast cancer survivors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years of age
  • Recent (within 6 months) completion of chemotherapy
  • Willing to attend 3 virtual exercise sessions per week
  • Able to take oral medications
  • Participant is willing and able to provide consent to participating in the study
  • Serum creatinine ≤ 1.5 x ULN or Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.

Exclusion criteria

  • Physical indications where performing exercise may be limited and/or contraindicated
  • Poorly-controlled hypertension (blood pressure > 160/95mmHg)
  • Current tobacco use (within 6 months)
  • Anabolic steroids use
  • Pitting edema
  • Currently undergoing chemotherapy
  • History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation).
  • Pregnant or plan to get pregnant during the study
  • Recent (within one month) or anticipated treatment with corticosteroids (except for short term use during the time of chemotherapy), androgens, progestational agents, or other appetite stimulants
  • Serum creatinine > 1.5 x ULN or Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation.
  • Currently taking creatine supplements

Treatment and study plan

Creatine

Dietary Supplement

Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.

Primary outcomes

  1. Change in strength in breast cancer survivors

    Time frame: From baseline to 12 weeks

    Participants will be evaluated for knee extensor strength via isometric maximum voluntary contraction at approximately 60° knee flexion.

  2. Change in functional capacity in breast cancer survivors

    Time frame: From baseline to 12 weeks

    Functional exercise capacity will be assessed via the 6 minute walk test (6MWT).

Secondary outcomes

  1. Change in intramuscular creatine and altering energy storage.

    Time frame: From baseline to 12 weeks

    Muscle Creatine, Phosphocreatine, and Adenosine-triphosphate content will be assessed in vivo by 31P-MRS using a whole body 3.0T MRI scanner.

  2. Change in muscle cross sectional area

    Time frame: From baseline to 12 weeks

    Magnetic resonance imaging will be used to capture the mid-thigh cross section.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • ThriveWell Cancer Foundation

Registry information

Official study title

The THRIVE Study: An Open-Label Randomized Trial of Exercise ± Creatine Supplementation to Augment the Adaptations of Exercise Training in Breast Cancer Survivors

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2019
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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